Ex Parte Werneth et al

Patent Trial and Appeal Board

Nov 17, 2017

13368685 (P.T.A.B. Nov. 17, 2017)

United States Patent and Trademark Office
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O.Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
13/368,685 02/08/2012 Randell L. Werneth 11760-700.200 2391
113314 7590
Michael R. Shevlin
9330 Fletcher Drive
La Mesa, CA 91941
EXAMINER
TON, MARTIN TRUYEN
ART UNIT PAPER NUMBER
3731
NOTIFICATION DATE DELIVERY MODE
11/21/2017 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
mshevlin @ cox.net
mike @ shevlinlaw.com
docketing@cpaglobal.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte RANDELL L. WERNETH and DAVID ZARBATANY
Appeal 2017-000822
Application 13/368,6851
Technology Center 3700
Before JEFFREY N. FREDMAN, KRISTI L. R. SAWERT, and
DAVID COTTA, Administrative Patent Judges.
COTTA, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims directed to a
cardiac orifice blocking device. The Examiner rejected the claims on appeal
as obvious under 35 U.S.C. § 103(a).
We affirm.
1 According to Appellants, the real party in interest is Atrial Innovations,
Inc. App. Br. 3.
Appeal 2017-000822
Application 13/368,685
STATEMENT OF THE CASE
The Specification discloses that in patients experiencing atrial
fibrillation (“AF”), the left atrium of the heart “often fails to contract with
any vigor” and, as a result, “blood tends to pool in the LAA [left atrial
appendage], which can lead to the formation of blood clots therein.” Spec.
13. Accordingly, “[djevices are needed” to “consistently and effectively
prevent clots from entering the atrium from the appendage.” Id. at 16.
The Specification discloses implant devices, including the
embodiment depicted in Figure 4E (reproduced below).
50
Figure 4E illustrates “an exemplary embodiment of an implant adapted to
prevent blood flow into the left atrial appendage.” Spec. 133. As reflected
in Figure 4E, “[ijmplant 50 includes proximal anchor 54, distal anchor
56,. . . interconnecting therapy elements 58,” and two barriers 53 and 57.
Id. at 177.
Claims 18-46 are on appeal. Claim 18 is illustrative and reads as
follows:
18. A cardiac orifice blocking device, comprising:
an anchoring portion comprising a proximal anchoring
portion and a distal anchoring portion, the proximal anchoring
portion being made from a shape memory material and adapted
to be anchored against left atrial tissue by self expansion, and
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Application 13/368,685
the distal anchoring portion adapted to be anchored against left
atrial appendage tissue;
a hub secured to the proximal and distal anchoring
portions;
a barrier portion comprising a proximal barrier secured to
the self expanding proximal anchoring portion, the proximal
barrier adapted to prevent blood from passing therethrough, and
a distal barrier portion secured to the distal anchoring portion.
App. Br. 18.
The claims stand rejected as follows:
Claims 18—29 and 31—37 were rejected under pre-AIA 35 U.S.C.
§ 103(a) as obvious over the combination of Vijay2 and Sutton.3
Claim 30 was rejected under pre-AIA 35 U.S.C. § 103(a) as obvious
over the combination of Vijay, Sutton and Krolik.4
Claims 38-46 were rejected under pre-AIA 35 U.S.C. § 103(a) as
obvious over the combination of Vijay, Sutton, and Eigler.5
OBVIOUSNESS OVER VIJAY AND SUTTON
Appellants argue claims 18—29 and 31—37 together. We designate
claim 18 as representative.
In rejecting claim 18 as obvious, the Examiner found that Vijay
disclosed an implantable cardiac orifice blocking device. Final Act.6 4.
With reference to Figure 13 (reproduced below), the Examiner found that
2 Vijay, US Patent No. 7,320,665 B2, issued Jan. 22, 2008 (“Vijay”).
3 Sutton et al., US Patent Publication No. 2003/0181942 Al, published Sept.
25, 2003 (“Sutton”).
4 Krolik et al., US Patent No. 6,969,396 B2, issued Nov. 29, 2005
(“Krolik”).
5 Eigler et al., US Patent Publication No. 2005/0288722 Al, published Dec.
29, 2005 (“Eigler”).
6 Office Action mailed December 2, 2015 (“Final Act.”).
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Application 13/368,685
Vijay disclosed a proximal anchoring portion (206), a distal anchoring
portion (208), a hub (218), proximal barrier (210), and a distal barrier (212).
Id.
Figure 13 is a schematic perspective view of an embodiment of Vijay’s
implantable expandable device. Vijay col. 3,11. 64—65. Upon deployment
of Vijay’s device, rotation of a cog wheel “expands the umbrellas 206, 208
and causes engagement of the barbs 214, 216.” Id. at col. 8,11. 2—9. The
Examiner found that Vijay’s device met all of the elements of claim 18 with
the exception of the requirement that the anchoring material be “made from
memory shape material” and “adapted to be anchored” by “self-expansion.”
Final Act. 4.
The Examiner found that Sutton disclosed a “device for occupying an
orifice within the heart” that included “self-expanding elastic structures . . .
formed of shape memory alloy materials.” Id. Based on the combined
disclosures of Vijay and Sutton, the Examiner concluded “it would have
been obvious to a person having ordinary skill in the art to replace the
mechanical expansion mechanism of the Vijay reference with a self-
expanding, shape memory structure.” Id. at 3. The Examiner explained that
this would be nothing more than the substitution of “one known method for
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Application 13/368,685
expanding a cardiac orifice blocking device (the mechanical cog system) . . .
with another known method of expanding a cardiac orifice blocking device
(self-expansion via shape memory material)” and that this substitution would
“yield predictable results.” Id.
We adopt the Examiner’s findings of fact and reasoning regarding the
scope and content of the prior art (Ans. 2—5; Final Act. 2—11) and agree that
claim 18 would have been obvious over Vijay and Sutton. We address
Appellant’s arguments below.
Appellants argue that “the addition of [Sutton’s] shape memory
material for self-expansion would not eliminate the cog wheel [in Vijay’s
device] since the device is pre-assembled with all the components required
for delivery of the umbrellas.” App. Br. 12—13. Appellants thus contend
that the substitution of materials proposed by the Examiner would not yield
predictable results. Id. We are not persuaded.
The function and purpose of the Vijay’s cog and is to allow
mechanical expansion of the umbrellas. Vijay col. 8,11. 2—10. Sutton
discloses “self-expanding elastic structures” as an alternative to mechanical
expansion mechanisms. Sutton 1 52. In finding that it would have been
obvious to modify Vijay’s cog system to use a self-expanding memory
material, the Examiner did not conclude that it would have been obvious to
add Sutton’s self-expanding material to Vijay’s device. Rather, the
Examiner concluded that it would have been obvious to replace Vijay’s
mechanical expansion mechanism with Sutton’s self-expanding material.
Final Act. 3 (“[I]t would have been obvious to a person having ordinary skill
in the art to replace the mechanical expansion mechanism of the Vijay
reference with a self-expanding, shape memory structure.”). As the
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Examiner explained, “the modified device will be using the actuator of the
secondary reference, which would eliminate the use of the cog wheel
actuator.” Ans. 3. The presence of a cog wheel in Vijay’s device thus does
not render the proposed combination unpredictable.
Appellants argue that Vijay “discloses no other alternative
embodiments without the cog wheel configuration for deployment” and that
“replacing the mechanical expansion mechanism of the Vijay reference with
a self-expanding, shape memory structure would change to principle of
operation.” App. Br. 13. We are not persuaded because both Vijay and
Sutton rely on the same principle of operation: securing and anchoring a
device by expansion within a confined area. Moreover, to the extent
changing from mechanical expansion to self-expansion is considered to be a
change in the principle of operation, it would not preclude a finding of
obviousness. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007)
(finding claim obvious notwithstanding that some reconstruction of the prior
art elements amounting to a change in the principle of operation of the pedal
sensor from mechanical to electrical would have been required to arrive at
the claimed invention).
Appellants argue that there is no motivation to combine the prior art in
the manner claimed and that the Examiner did not “identify a reason that
would have prompted a person of ordinary skill in the relevant field to
replace the mechanical expansion mechanism of the Vijay reference with a
self-expanding, shape memory structure.” App. Br. 14 (quotation omitted).
We are not persuaded. As the Examiner explained, “a person having
ordinary skill in the art at the time of invention would recognize through the
teachings of the Sutton reference, that self-expanding, shape memory
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Application 13/368,685
structures for the device is an alternative method of expansion to a size­
adjusting mechanical expansion.” Ans. 4. Accordingly, the Examiner
concluded that using self-expanding material in Vijay’s device was “a
simple substitution of one known method of expanding a cardiac blocking
device (the mechanical cog system) with another known method of
expanding a cardiac orifice blocking device (self-expansion via shape
memory material)” which would “yield predictable results.” Id.; see KSR,
550 U.S. at 416 (“when a patent claims a structure already known in the
prior art that is altered by the mere substitution of one element for another
known in the field, the combination must do more than yield a predictable
result”).
Accordingly, we affirm the Examiner’s rejection of claim 18 as
obvious over the combination of Vijay and Sutton. Because they were not
argued separately, claims 19-29 and 31—37 fall with claim 18.
OBVIOUSNESS OVER VIJAY, SUTTON, AND KROLIK
Appellants do not advance any new arguments with respect to this
rejection, instead arguing only that Krolik “does not cure the defects of
Vijay and Sutton regarding claim 18.” App. Br. 15. Accordingly, we affirm
the Examiner’s rejection of claim 30 over the combination of Vijay, Sutton
and Krolik for the reasons discussed in connection with claim 18.
OBVIOUSNESS OVER VIJAY, SUTTON, AND EIGLER
Appellants do not advance any new arguments with respect to this
rejection, instead arguing only that Eigler “does not cure the defects of Vijay
and Sutton regarding claim 18.” App. Br. 16. Accordingly, we affirm the
Examiner’s rejection of claim 3 8—46 over the combination of Vijay, Sutton
and Eigler for the reasons discussed in connection with claim 18.
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SUMMARY
For the reasons set forth herein, and those provided in the Examiner’s
Answer and Final Office Action, we affirm the Examiner’s rejection of
claims 18—29 and 31—37 as obvious over the combination of Vijay and
Sutton, claim 30 as obvious over the combination of Vijay, Sutton and
Krolik, and claims 3 8 46 as obvious over the combination of Vijay, Sutton,
and Eigler.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).
AFFIRMED
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